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RECRUITING
NCT04853251
PHASE4

A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

Summary

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Official title: A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2021-12-14

Completion Date

2028-04-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DEVICE

PDS Implant With Ranibizumab 100 mg/ml

Ranibizumab 100 mg/mL will be delivered via PDS

DRUG

LUCENTIS (Ranibizumab Injection)

Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.

Locations (50)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retina Associates of Southern California

Huntington Beach, California, United States

California Eye Specialists Medical group Inc.

Pasadena, California, United States

Retinal Consultants Med Group

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Orange County Retina Med Group

Santa Ana, California, United States

Macula Retina Vitreous Research Institute

Torrance, California, United States

Southwest Retina Consultants

Durango, Colorado, United States

Advanced Vision Research Institute

Longmont, Colorado, United States

Retina Group of New England

Waterford, Connecticut, United States

Retina Specialty Institute

Pensacola, Florida, United States

Ft Lauderdale Eye Institute

Plantation, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

University Retina and Macula Associates, PC

Lemont, Illinois, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Retina Associates of Kentucky

Lexington, Kentucky, United States

Maine Eye Center

Portland, Maine, United States

The Retina Care Center

Baltimore, Maryland, United States

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, United States

Retina Group of Washington

Chevy Chase, Maryland, United States

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, United States

Associated Retinal Consultants PC

Royal Oak, Michigan, United States

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Seeta Eye Centers

Poughkeepsie, New York, United States

Western Carolina Retinal Associate PA

Asheville, North Carolina, United States

Duke Eye Center

Durham, North Carolina, United States

Fargo Retina Consultants

Fargo, North Dakota, United States

Cincinnati Eye Institute

Blue Ash, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Erie Retina Research

Erie, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Palmetto Retina Center

Florence, South Carolina, United States

Palmetto Retina Center, LLC

West Columbia, South Carolina, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina PC

Nashville, Tennessee, United States

Panhandle Eye Group LLP Southwest Retina Specialists

Amarillo, Texas, United States

Austin Retina Associates

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Retina Consultants of Texas

Schertz, Texas, United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Kapoor Institute

Norfolk, Virginia, United States

Retina Institute of Virginia

Richmond, Virginia, United States

Spokane Eye Clinical Research

Spokane, Washington, United States